Job Title: Clinical Research Coordinator
Department: Clinical Studies
Reports To: Manager of Clinical Operations
Location: Trumbull, CT
Terms: Full-time (40 hours)
Requirements: Monday-Friday, 8-hour shift
FLSA Status: Exempt

POSITION SUMMARY

The Clinical Research Coordinator is responsible for keeping all subject material and clinical records organized and accessible to the principal investigator and other members of the clinical research team. They must adhere to regulatory trial standards and participate in subject recruitment efforts, among other duties.

The Clinical Research Coordinator needs to engage with research subjects and other medical professionals, and explain what is expected and understand their concerns, requiring great interpersonal and communicative skills.

ESSENTIAL FUNCTIONS

Critical features of this position are listed below and may be revised, updated, or reassigned at management’s discretion in accordance with business needs or other factors.

• Overseeing multiple clinical trials and keeping records organized.
• Collecting and analyzing data obtained from subject’s medical records.
• Informing participants about study objectives.
• Reviewing paperwork returned and verifying all forms are complete. If not complete, missing information needs to be retrieved.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and company and sponsoring agency policies and procedures.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Companies Research Integrity Policy and other misconduct as described in Companies Code of Conduct.
• Prepares and maintains all study materials These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, accountability logs.
• Liaison to laboratory regarding test results.
• Participating in subject recruitment efforts.
• Assisting laboratory with sample archival and storage.
• Engaging with subjects and understanding their concerns.
• Maintains effective and ongoing communication with sponsors, research participants and PI during the study.
• Works with study clinics on study subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members.
• Attends investigator meetings as required or requested by the PI.
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
• Collects data as required by the protocol.
• Maintains study timelines.
• Maintains adequate inventory of study supplies (i.e., research kits, study materials etc.).
• Works with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management.
• Works closely with the Director of Clinical Research to establish all IRB materials, and ensures all ongoing studies meet the regulatory and FDA guidelines for clinical trials.

MINIMUM QUALIFICATIONS

• At least three years as a clinical research professional (certification as a CCRC is desired).
• At least three years’ experience with provider credentialing protocols, resources, process, and regulatory requirements.
• At least three years of experience handling biospecimens.
• Bachelor’s degree in a scientific, health related, or business administration required.
• Strong Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts.
• Detail-oriented and experience working with Microsoft office.

KNOWLEDGE, SKILLS, AND ABILITIES

• Pleasant and professional demeanor with the ability to work collaboratively across the organization.
• Ability to manage multiple tasks simultaneously.
• Ability to prioritize and perform multiple tasks in a dynamic environment.
• Strong interpersonal, management, critical thinking, decision making skills.
• Strong verbal and written communication skills.
• Solid interpersonal skills.
• Calm and reasoned judgment.
• Analytical mindset.
• Excellent organizational skills and attention to detail.
• Strong sense of ethical and moral attitudes necessary for maintaining the confidentiality of patient information.
• Ability to work overtime hours, as required.
• Ability to read, understand, and follow SOPs, validation protocols, etc. and to complete documentation in a clear, accurate manner.
• Willingness to continually self-educate.

SUPERVISORY RESPONSIBILITIES

• No direct supervisory responsibilities.